New England Journal of Medicine SEPTEMBER 10, 2009

Ticagrelor versus Clopidogrel in Patients with Acute Coronary Syndromes

Lars Wallentin, Richard C. Becker, Andrzej Budaj, Christopher P. Cannon, Robert F. Emanuelsson, C. Michael Gibson, et al.

Bottom Line

In patients with acute coronary syndromes (ACS), ticagrelor significantly reduced the composite rate of death from vascular causes, myocardial infarction, or stroke compared to clopidogrel at 12 months, without increasing the rate of overall major bleeding.

Key Findings

1. The primary endpoint (composite of vascular death, myocardial infarction, or stroke) occurred in 9.8% of the ticagrelor group compared to 11.7% in the clopidogrel group at 12 months (hazard ratio 0.84; 95% CI, 0.77 to 0.92; P<0.001).
2. Ticagrelor demonstrated a reduction in the rate of myocardial infarction (5.8% vs. 6.9%, P=0.005) and vascular death (4.0% vs. 5.1%, P=0.001) compared to clopidogrel.
3. There was no significant difference in the primary safety outcome of total PLATO-defined major bleeding between the ticagrelor and clopidogrel groups (11.6% vs. 11.2%, P=0.43).
4. Ticagrelor was associated with higher rates of non-procedure-related major bleeding (4.5% vs. 3.8%, P=0.03) and dyspnea compared to clopidogrel.

Study Design

Design
RCT
Double-Blind
Sample
18,624
Patients
Duration
12 mo
Median
Setting
Multicenter, International
Population Patients hospitalized for acute coronary syndromes (with or without ST-segment elevation) with onset of symptoms within the previous 24 hours.
Intervention Ticagrelor (180-mg loading dose, 90 mg twice daily)
Comparator Clopidogrel (300-600 mg loading dose, 75 mg daily)
Outcome Composite of death from vascular causes, myocardial infarction, or stroke

Study Limitations

The trial was a double-blind, double-dummy study, which required clopidogrel patients to receive a placebo loading dose, potentially influencing bleeding perceptions.
Higher rates of dyspnea and treatment discontinuation observed in the ticagrelor arm may have introduced some potential for informative censoring.
Subgroup analyses, including those by geographic region or specific clinical features, were not powered for definitive conclusions and carry a risk of type I errors.
The study required patients to have been stable enough to potentially be randomized within 24 hours, which may limit generalizability to patients presenting with extreme instability or early mortality.

Clinical Significance

The PLATO trial established ticagrelor as a superior alternative to clopidogrel in managing patients with ACS, leading to a change in standard of care toward more potent P2Y12 inhibition for reducing ischemic events without a trade-off in overall major bleeding.

Historical Context

Prior to PLATO, clopidogrel was the standard of care for dual antiplatelet therapy in ACS. PLATO challenged this by introducing a direct-acting, reversible P2Y12 inhibitor, offering faster and more consistent platelet inhibition, which set a new benchmark for efficacy in ACS management.

Guided Discussion

High-yield insights from every perspective

Med Student
Medical Student

What is the primary pharmacological difference between ticagrelor and clopidogrel regarding their binding to the P2Y12 receptor and the requirement for metabolic activation?

Key Response

Clopidogrel is a thienopyridine prodrug that requires a two-step hepatic metabolism via CYP450 enzymes to form an active metabolite that binds irreversibly to the P2Y12 receptor. In contrast, ticagrelor is a direct-acting cyclopentyltriazolopyrimidine that does not require metabolic activation and binds reversibly to the receptor, leading to a faster onset and offset of antiplatelet action.

Resident
Resident

A patient started on ticagrelor for ACS complains of new-onset shortness of breath without signs of pulmonary edema or wheezing. How should this be managed, and what is the likely underlying mechanism?

Key Response

Dyspnea occurred in approximately 14% of patients in the PLATO trial. It is typically transient and rarely requires discontinuation. The hypothesized mechanism involves the inhibition of adenosine reuptake by ticagrelor, leading to increased local adenosine levels that stimulate pulmonary vagal C-fibers. Management involves ruling out cardiac/pulmonary causes and providing reassurance; if intolerable, a switch to clopidogrel or prasugrel may be necessary.

Fellow
Fellow

The PLATO trial demonstrated a significant reduction in vascular and all-cause mortality, a finding not observed in the TRITON-TIMI 38 trial for prasugrel. What aspects of the PLATO study design or drug properties might account for this unique mortality benefit?

Key Response

Unlike TRITON-TIMI 38, which only enrolled patients with known coronary anatomy intended for PCI, PLATO included a broader ACS population (NSTE-ACS and STEMI) regardless of initial management strategy (medical vs. invasive). Additionally, ticagrelor's mortality benefit may be linked to pleiotropic effects, such as increased adenosine levels which may provide cardioprotection and modulate inflammatory responses, though this remains a subject of ongoing research.

Attending
Attending

In the PLATO trial, a significant interaction was noted between treatment effect and geographic region, specifically in North America. What was the suspected cause of this variation, and how does it dictate current prescribing practices?

Key Response

The North American subgroup appeared to derive less benefit from ticagrelor. Post-hoc analysis suggested this was due to higher maintenance doses of aspirin (typically >300mg) used in the US at the time. High-dose aspirin may interfere with the efficacy of ticagrelor. Consequently, it is now a standard of care and a black-box warning to maintain aspirin at a low dose (81mg daily) when used in conjunction with ticagrelor.

Scholarly Review

Critical appraisal through the lens of expert reviewers and guideline development

PhD
PhD

The PLATO trial reported no significant difference in 'total major bleeding' but a significant increase in 'non-CABG-related major bleeding.' Critically evaluate the impact of using composite safety endpoints in trials where surgical and non-surgical bleeding events are pooled.

Key Response

Pooling CABG and non-CABG bleeding can mask the true safety profile because surgical bleeding is often driven by the timing of the last dose rather than the drug's inherent potency. By isolating non-CABG bleeding, researchers can better identify the spontaneous and procedure-related bleeding risk patients will face in daily practice. This distinction is vital for determining the 'Net Clinical Benefit' of a potent antiplatelet agent over a less potent one.

Journal Editor
Journal Editor

Considering the 'geographic interaction' observed in PLATO, should the primary results have been downgraded due to a lack of global consistency, or was the aspirin-interaction hypothesis sufficient to maintain the study's internal validity?

Key Response

A seasoned reviewer would flag the North American subgroup result (p-interaction = 0.045) as a potential threat to generalizability. However, the biological plausibility of the aspirin interaction and the overwhelming statistical significance of the global result (p < 0.001) usually justify the primary conclusion. Editors must weigh whether a post-hoc explanation for a failed subgroup is 'hypothesis-generating' or a definitive clarification of the data.

Guideline Committee
Guideline Committee

Based on the evidence from PLATO, how do current ACC/AHA and ESC guidelines prioritize ticagrelor over clopidogrel for patients with NSTE-ACS, and what are the specific Level of Evidence (LOE) ratings for this recommendation?

Key Response

Current guidelines (e.g., 2014 AHA/ACC NSTE-ACS and 2023 ESC ACS guidelines) generally recommend ticagrelor over clopidogrel (Class I, LOE B-R or A) for all patients at moderate-to-high risk of ischemic events, regardless of initial invasive or conservative strategy. This is a direct result of PLATO's finding that ticagrelor was superior in reducing MI and death without an increase in overall major bleeding, though clopidogrel remains the choice if oral anticoagulation is also required (triple therapy) or if bleeding risk is prohibitive.

Clinical Landscape

Noteworthy Related Trials

2001

CURE Trial

n = 12,562 · NEJM

Tested

Clopidogrel added to aspirin

Population

Patients with acute coronary syndromes without ST-segment elevation

Comparator

Placebo added to aspirin

Endpoint

Composite of cardiovascular death, nonfatal myocardial infarction, or stroke

Key result: The addition of clopidogrel to aspirin significantly reduced the rate of cardiovascular death, MI, or stroke compared to placebo.
2007

TRITON-TIMI 38 Trial

n = 13,608 · NEJM

Tested

Prasugrel

Population

Patients with acute coronary syndromes with scheduled percutaneous coronary intervention

Comparator

Clopidogrel

Endpoint

Composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke

Key result: Prasugrel was associated with a higher reduction in ischemic events compared to clopidogrel but with an increased risk of major bleeding.
2010

CURRENT-OASIS 7 Trial

n = 25,086 · NEJM

Tested

Double-dose clopidogrel (600mg loading, 150mg daily for 6 days, then 75mg)

Population

Patients with acute coronary syndromes referred for percutaneous coronary intervention

Comparator

Standard-dose clopidogrel (300mg loading, 75mg daily)

Endpoint

Composite of cardiovascular death, myocardial infarction, or stroke at 30 days

Key result: High-dose clopidogrel did not significantly reduce the primary endpoint compared to standard-dose, though it reduced stent thrombosis rates in the PCI subgroup.

Tailored to your role

Want this tailored to you?

Add your specialty or training stage to get role-specific takeaways and more questions.

Personalize this analysis